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NCT05949047 · ClinicalTrials.gov registry record · NA

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

A NA study of Stress and Emotion Regulation, sponsored by Bryan Denny.

Recruiting
Registry status
NA
Development phase
270
Enrollment target
1
Study location

NCT05949047 is a NA study of Stress and Emotion Regulation that is actively recruiting participants, run by Bryan Denny. The registered enrollment target is 270 participants, below the 784-participant average among 152 other Stress trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05949047, a NA study of Stress and Emotion Regulation, is actively recruiting participants, sponsored by Bryan Denny.

RECRUITING
Registry status
NA
Development phase
270 participants
Enrollment target
1
Study location

Study Summary

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability d

Interventions

  • BEHAVIORAL Cognitive Emotion Regulation Training via Psychological Distancing
  • BEHAVIORAL Cognitive Emotion Regulation Training via Reinterpretation

Study Locations (1)

Texas

  • Rice University - Houston

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2023-09-14
Est. Completion 2027-05-31
Phase NA

Sponsor

Bryan Denny

2 total trials

What the Registry Record Tells You About NCT05949047

The ClinicalTrials.gov registry entry for NCT05949047 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 784-participant average among 152 other Stress trials with a reported enrollment target (66% lower). The listed sponsor is Bryan Denny, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Emotion Regulation Training via Psychological Distancing is the first listed.

NCT05949047 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05949047 about?

NCT05949047 is a clinical study titled "Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease". Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across ...

What is the current status of trial NCT05949047?

This trial is currently recruiting. It is a NA study. The enrollment target is 270 participants. The study started on 2023-09-14. Estimated completion is 2027-05-31.

What conditions does trial NCT05949047 study?

This clinical trial studies the following conditions: Stress, Emotion Regulation, Emotions, Caregivers, Psychological.

What interventions are being tested in trial NCT05949047?

The interventions under investigation include: Cognitive Emotion Regulation Training via Psychological Distancing (BEHAVIORAL), Cognitive Emotion Regulation Training via Reinterpretation (BEHAVIORAL).

Who is sponsoring clinical trial NCT05949047?

This trial is sponsored by Bryan Denny, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05949047 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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